The concerned parties, whose viewpoints could play a significant role in shaping the final proposals, are far from united on some of the EU's proposals. A large number of companies have ploughed significant resources into developing anti-counterfeiting technologies and big pharma's responses may not make comfortable reading for them. In particular mass serialisation, which some people have tipped to be a central tenant of the fight against counterfeiting, is far from universally welcomed by big pharma. Bristol-Myers Squibb (BMS) is arguably the harshest critic of the technology, citing concerns over the reliability of the technology, the fact no one system is agreed on and who owns and runs the system.
The Pharmaceutical Research and Manufactures of America (PhRMA) also believes that the system does not have a place in current anti-counterfeiting legislation, stating that the time and effort required to implement an effective serialisation makes it an inferior option to others available. There is some support within big pharma though, with Johnson and Johnson (J&J), Roche and Pfizer all backing the proposal, admittedly with some caveats. Pfizer is broadly in favour but insists that it would only be effective if tamper evident seals and a ban on repackaging are implemented, two topics the company places considerable importance on throughout its response. J&J and Roche both call for the Commission to collaborate with the European Federation of Pharmaceutical Industries and Associations (EFPIA) which has proposed a system based upon checking the product only when it enters and leaves the supply chain.
However, BMS raises the point that any measure by the commission is a Europe wide solution to a global issue, saying if mass serialisation is to be implemented collaboration with the FDA is essential. Achieving global harmonization could prove challenging, as it could within the EU with regards to penalties for counterfeiters. PhRMA's response seeks for the EU to ensure that penalties are the same in all member states, urging it to exercise its power to impose laws regarding sentencing, which is only used in exceptional circumstances. None of the companies involved raise this legislative issue but the need for heavier sentences is echoed by Pfizer, Roche and J&J, with the latter proposing that negligence is also considered as a criminal act.
Given the harm that can be caused by counterfeit medicines, for example the 14 people who died in China after being administered with human immunoglobulin containing a fake ingredient, many would conclude that penalties in the EU are currently lenient. The Chinese counterfeiter was sentenced to life imprisonment for his crime, a stark contrast to punishments within the EU, of which Britain currently has among the strictest penalties with a potential 10 year jail term under the Trademarks Act.
Other issues big pharma is united on include the need for tamper evident seals and regulation of the supply chains brokers, agents and dealers.